Novo Nordisk has reached a resolution with the US federal government and the states about an investigation launched in February 2011 concerning sales and marketing practices for Victoza, a medicine to treat type 2 diabetes.
The investigation was disclosed by Novo Nordisk for the first time in a company announcement on 16 February 2011.
The settlement resolves claims alleging Novo Nordisk did not fully comply with communicating safety information based on a U.S. Food and Drug Administration (FDA)-approved Risk Evaluation and Mitigation Strategy (REMS) for Victoza. Under the terms of the settlement agreement, Novo Nordisk will pay approximately 46.5 million US dollars to the federal government and to states that reimbursed for Victoza under their Medicaid programmes. Additionally, Novo Nordisk will pay 12.15 million dollars to resolve a complaint filed by the government on behalf of the FDA in federal court. In connection with this settlement, the Company has also resolved several private whistle-blower cases related to the government’s investigation. The US Department of Health & Human Services, Office of Inspector General, determined that it would not seek a Corporate Integrity Agreement as part of this settlement.
“At Novo Nordisk, we take our responsibility to communicate the safety and clinical benefits of our medicines seriously, and remain committed to properly addressing safety questions healthcare professionals ask every day,” said Douglas Langa, executive vice president, North America Operations. “Our focus will always be to ensure that those caring for patients have the data they need to make the most informed treatment decision. While we do not agree with the US government’s legal conclusions and deny any wrongdoing, we’re pleased to have negotiated a resolution that allows the company to return its full attention to developing medicines that help improve the lives of patients.”